Trial · NCT04234204
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS) | Baseline to Week 4 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Primary | Mean change from baseline in the frequency of moderate to severe VMS | Baseline to Week 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Primary | Mean change from baseline in the severity of moderate to severe VMS | Baseline to Week 4 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Primary | Mean change from baseline in the severity of moderate to severe VMS | Baseline to Week 12 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Mean change from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Secondary | Mean change from baseline to each week in the severity of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Mean percent reduction from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Secondary | Percent reduction ≥50% from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Ratio of the participants with ≥50% reduction in frequency will be reported. |
| Secondary | Percent reduction at 100% from baseline to each week in the frequency of moderate and severe VMS | Baseline to Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 11, 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Ratio of the participants with ≥ 100% reduction in frequency will be reported. |
| Secondary | Mean change from baseline in the frequency of moderate to severe VMS | Baseline to Week 24 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Secondary | Mean change from baseline in the severity of moderate to severe VMS | Baseline to Week 24 | The severity of VMS will be calculated using a weighted average of VMS events. |
| Secondary | Number of Participants With Adverse Events | Up to 27 Weeks | An adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Number of Participants With Adverse Events Based on Severity | Up to 27 Weeks | An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Change From Baseline in Endometrial Thickness | Baseline and Week 24 | Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU). |
| Secondary | Percentage of Participants With Endometrial Hyperplasia and/or Endometrial Cancer | Up to 24 Weeks | Endometrial hyperplasia is thickening of the lining of the uterus. Endometrial cancer is cancer of the lining of the uterus. |
| Secondary | Number of Participants With Vital Sign Abnormalities and/or Adverse Events | Up to 27 Weeks | Number of participants with potentially clinically significant vital sign values will be reported. |
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs) | Up to 27 Weeks | Number of participants with potentially clinically significant ECG values will be reported. |
| Secondary | Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs) | Up to 27 Weeks | Number of participants with potentially clinically significant laboratory values will be reported. |
| Secondary | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) | Baseline, Week 24 and Week 27 | Change from baseline in serum concentrations of BSAP will be reported. |
| Secondary | Change From Baseline in Procollagen Type 1 Aminoterminal Propeptide (P1NP) | Baseline, Week 24 and Week27 | Change from baseline in serum concentrations of P1NP will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04234204/registered